media – Page 297 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Sridhar Babu inaugurates Innovera’s new site in New Jersey

Minister Sridhar Babu inaugurated Innovera Pharma’s latest site in New Jersey, USA, during his recent visit. The new facility is expected to expand Innovera Pharma’s research, development, and production capabilities. The roots of this collaboration were established during a key meeting at the World Economic Forum (WEF) in Davos, Switzerland wherein Telangana CM Revanth Reddy and Sridhar Babu led a delegation earlier this year. These discussions paved the way for the company to invest in Telangana. Solidifying this partnership, within 30 days of the announcement, a ceremony was held on February 22, 2024, in Suryapet, Telangana. This event marked the commencement of a project aimed at enhancing local manufacturing capabilities and infrastructure. The partnership highlights how regional governments can support enterprises in scaling their operations globally. By fostering such alliances, this active partnership not only strengthens Innovera’s global presence but also reinforces Telangana’s strides to develop the pharmaceutical and biotechnology ...
- Source: drugdu
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- June 15, 2024
Pfizer investigational gene therapy for DMD fails in Phase 3 study

Pfizer announced that CIFFREO, a Phase 3 global, multicentre, randomised, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD) did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with the gene therapy compared to placebo. The primary endpoint in the final analysis was assessed by change in the North Star Ambulatory Assessment (NSAA) a year after treatment. Key secondary endpoints, including 10-metre run/walk velocity and time to rise from floor velocity, also did not show a significant difference between participants treated with fordadistrogene movaparvovec and placebo. The overall safety profile of fordadistrogene movaparvovec in the CIFFREO trial was manageable, with mostly mild to moderate adverse events, and treatment-related serious adverse events generally responding to clinical management. Pfizer will continue to closely monitor all participants enrolled in the study and ...
- Source: drugdu
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- June 15, 2024
drugdu

The amyotrophic lateral sclerosis (ALS) market across the 8MM (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and Canada) is projected to grow at a compound annual growth rate (CAGR) of 15 per cent from $317 million in 2019 to $1.28 billion in 2029, forecasts drugdu. The key opinion leaders (KOLs) interviewed by drugdu identified the greatest unmet needs within the ALS space. These entail earlier diagnosis, disease-modifying therapies (DMTs), identification of biomarkers, and efficacious first-line treatment options. However, the consensus amongst them is that the need to diagnose ALS early and the development of DMTs is imperative for any change to take place within the treatment space. Momna Ali, Healthcare Analyst at drugdu, comments, “Due to the variety in the presentation of ALS development and symptoms, there have been historical difficulties in diagnosing patients in a timely manner. Pharmaceutical companies have an opportunity to educate physicians both ...
- Source: drugdu
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- June 15, 2024
IIIT-Delhi’S AMRSense secure second prize at Trinity Challenge on AMR

The Trinity Challenge has announced the winners of its second competition (the Trinity Challenge on Antimicrobial Resistance), aimed at tackling the escalating threat of antimicrobial resistance (AMR). The awarded projects focus on addressing critical data gaps in communities and lower-income countries, which are disproportionately impacted by antibiotic-resistant infections. IIIT-Delhi announces that the project “AMRSense: Empowering Communities with a Proactive One Health Ecosystem,” led by Prof Tavpritesh Sethi in collaboration with CHRI-PATH, 1mg.com, and ICMR, has secured the joint second prize. The project shares this honor with “OASIS: OneHealth Antimicrobial Stewardship for Informal Health Systems,” also from India. Each joint second prize winner will receive £600,000 in funding over the next three years. All winners will also benefit from ongoing post-award innovation and scaling support. AMRSense addresses the challenges of engaging, motivating, and training community health workers (CHWs) in AMR surveillance and management, compounded by the lack of a comprehensive data ...
- Source: drugdu
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- June 15, 2024
【EXPERT Q&A】The requirement of an EU Representative for CE certification brings several benefits and impacts?

Drugdu.com expert’s response: The benefits and impacts of requiring an EU Representative for CE certification can be summarized as follows: Benefits : 1.Communication Bridge: An EU Representative serves as an intermediary between manufacturers and EU authorities, effectively communicating and handling technical, regulatory, and after-sales issues related to products. This bridging role significantly simplifies the communication process between manufacturers and EU authorities, improving the efficiency of problem-solving. 2.Compliance Assurance: Through an EU Representative, manufacturers can ensure their products meet EU regulatory requirements, mitigating the risk of compliance violations due to unfamiliarity with local regulations. The EU Representative’s familiarity and understanding of EU regulations can provide manufacturers with guidance and support in terms of compliance. 3.Clear Responsibility: In the event of product issues, EU authorities can directly contact the EU Representative to take prompt action, such as product recalls. This clear responsibility approach enhances the efficiency of problem resolution, reducing delays ...
- Source: drugdu
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- June 14, 2024
First-Line PSA Testing More Cost-Effective Than First-Line MRI for Prostate Cancer Screening

Current prostate cancer (PCa) screening protocols typically begin with prostate-specific antigen (PSA) testing, which, if elevated, may lead to further assessment using multiparametric magnetic resonance imaging (mpMRI). Now, a cost-effectiveness analysis has revealed that using biparametric magnetic resonance imaging (bpMRI) as an initial screening tool is less cost-effective than the traditional approach of first-line PSA testing followed by mpMRI. This conclusion held true even when assuming no cost for bpMRI, indicating that the financial savings do not compensate for the drawbacks of using the first-line MRI approach. A team of researchers from Fred Hutchinson Cancer Center (Seattle, WA, USA), in collaboration with other institutions, developed a microsimulation model to compare the effectiveness and cost-efficiency of first-line bpMRI versus first-line PSA with reflex mpMRI for prostate cancer screening. The study showed that initiating screening with MRI significantly increased the incidence of false positives, unnecessary prostate biopsies, and overdiagnoses, without a corresponding ...
- Source: drugdu
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- June 14, 2024
Self-Taught AI Tool Diagnoses and Predicts Severity of Common Lung Cancer

A computer program powered by artificial intelligence (AI) and trained on nearly half a million tissue images can effectively diagnose cases of adenocarcinoma, the most prevalent type of lung cancer. The computer program developed and tested by researchers at NYU Langone Health (New York, NY, USA) provides an unbiased, detailed, and reliable second opinion for patients and oncologists regarding the presence of the cancer and the possibility and timing of its return, also known as its prognosis. This is because the program incorporates structural features of tumors from 452 adenocarcinoma patients, who are among the more than 11,000 patients in the U.S. National Cancer Institute’s Cancer Genome Atlas. Importantly, the program operates independently and is “self-taught,” deciding by itself which structural features are most critical for assessing the severity of the disease and its impact on tumor recurrence. In their research, the algorithm, known as histomorphological phenotype learning (HPL), successfully ...
- Source: drugdu
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- June 14, 2024
FDA Grants Emergency Use Authorization to Roche’s Cobas Liat SARS-CoV-2, Influenza A/B, & RSV Nucleic Acid Test

Don Tracy, Associate Editor The cobas is classified as a four-in-one molecular test that can identify SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus from a single nasopharyngeal or anterior nasal swab sample. The FDA has granted Emergency Use Authorization (EUA) to Roche’s cobas liat SARS-CoV-2, Influenza A/B & respiratory syncytial virus (RSV) nucleic acid test. According to the company, it is a four-in-one molecular test, defined as an automated multiplex RT-PCR assay that can detect SARS-CoV-2, influenza A, influenza B, and RSV from a nasal swab sample. Additionally, Roche reported that full results can be expected in 20 minutes via a compact analyzer.1 “Diagnostics play a critical role in the fight against respiratory illness,” said Matt Sause, CEO, Roche Diagnostics, in a press release. “We are proud to provide this innovative test to address the significant burden placed on healthcare systems. Now, healthcare professionals will be able to ...
- Source: drugdu
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- June 14, 2024
Avidity Bio’s RNA Therapy Flashes Early Signs of Treating a Muscular Dystrophy’s Root Cause

Avidity Biosciences’ RNA therapy for facioscapulohumeral muscular dystrophy has preliminary clinical data showing it knocked down expression of a gene that causes this rare disease. More details will be presented at a medical conference this week. By Frank VinluanAn experimental RNA therapy from Avidity Biosciences has early clinical trial results showing it reduced by half the expression of a gene at the root of a rare, inherited form of muscular dystrophy with no FDA-approved therapies. Furthermore, patients in the study are showing signs of regaining muscle function. Based on these initial results announced Wednesday, Avidity said it plans to accelerate the start of additional cohorts in the Phase 1/2 study that could support an application seeking regulatory approval in this disease, facioscapulohumeral muscular dystrophy (FSHD). More details about the data are coming soon. Avidity plans to present the preliminary results during the Annual FSHD Society International Research Congress meeting, which ...
- Source: drugdu
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- June 14, 2024
LucyTx announces additional $12.5m research funding for neurological diseases

Lucy Therapeutics (LucyTx) has announced it has raised $12.5m in additional funding to develop potentially new drugs and advance the company’s research programmes for neurological diseases. The funding, provided by existing investors, Engine Ventures and Safar Partners, with recent participation from the Bill & Melinda Gates Foundation, the Michael J. Fox Foundation and £1.6m from Parkinson’s UK’s Biotech programme, brings the company’s total funding to $36m. The new project aims to develop novel therapies that are based on mitochondrial small-molecule treatments and diagnostic biomarkers for Alzheimer’s (AD) and Parkinson’s disease (PD), as well as continue the development of a novel drug target for Rett syndrome, a rare genetic neurological and developmental disorder that affects brain development. AD and PD are the two most common neurodegenerative diseases worldwide, affecting around 24 million and ten million people, respectively. Using LucyTx’s platform, the team will analyse a variety of disease drivers central to ...
- Source: drugdu
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- June 14, 2024

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